CRED ERP 25

Biosimilar medicines: definition and features A biosimilar medicine (‘biosimilar’) is a medicine highly similar to another biological medicine already

Due to the natural variability of the biological source and to the manufacturing process unique to each manufacturer, minor differences can occur between the biosimilar and its reference medicine (table 1 and figure 3). Strict controls are always in place during manufacturing to ensure that minor differences do not affect the way the medicine works or its safety. Thus, these differences are not clinically meaningful in terms of safety or efficacy.

marketed in the EU (the so-called ‘reference medicine’) 1, 2 . Companies can market approved biosimilars once the period of market protection of the reference medicine expires (after 10 years).

Since biosimilars are a type of biological medicine, all features pertinent to biological medicines apply.

Table 1. Specific features of biosimilar medicines

Highly similar to the reference medicine

The biosimilar has physical, chemical and biological properties highly similar to the reference medicine’s. There may be minor differences from the reference medicine which are not clinically meaningful in terms of safety or efficacy. No differences are expected in clinical performance. Clinical studies that support the approval of a biosimilar confirm that any differences will not have an effect on safety and efficacy. Minor variability is only allowed when scientific evidence shows that it does not affect the safety and efficacy of the biosimilar. The range of variability allowed for a biosimilar is the same as that allowed between batches of the reference medicine. This is achieved with a robust manufacturing process to ensure that all batches of the medicine are of proven quality.

No clinically meaningful differences compared with the reference medicine Variability of biosimilar kept within strict limits

Same strict standards of quality, safety and efficacy

Biosimilars are approved according to the same strict standards of quality, safety and efficacy that apply to any other medicine.

When the active substance is a protein, both the biosimilar and the reference medicine must contain the same protein (i.e. amino acid sequence) and the same ‘3D’ structure (folding of the protein). Amino acid sequence and folding are the main factors that determine biological activity, which must be the same for the biosimilar and the reference medicine. For the finished medicine, both biosimilar and reference medicine must have the same posology and route of administration. Some differences may

be allowed if they have no effect on safety and efficacy - for example differences in the formulation of the medicine (e.g. excipients), presentation (e.g. powder to be reconstituted versus solution ready for injection) and administration device (e.g. type of delivery pen). To date, the great majority of biosimilars approved in the EU contain proteins as active substances. Table 2 lists the classes of biological medicines for which biosimilars have been approved in the EU.

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